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3rd shift QA Inspector

The Staffing Resource Group, Inc • Kendall, FL

Posted 5 days ago

Job Snapshot

Full-Time
Travel - None
Experience - 3 years
Degree - High School
$18.00 - $20.00/Hour
Pharmaceutical
QA - Quality Control

Job Competition

11

Applicants

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Job Description

3rd shift QA Inspector

Full-time direct hire opportunity with a large pharmaceutical company!

Tuesday- Saturday; 10PM- 6:30 AM

  • Inspect inbound components for manufacturing / packaging activity.
  • Enforce cGMP compliance of manufacturing and packaging staff.
  • Review and release Labels assuring compliance with quality specifications.
  • Ensure that manufacturing and packaged products meet quality and customer standards and guidelines.
  • Review in process and completed batch records and shipment paperwork for accuracy, completeness and adherence to cGMP.
  • Assist in conducting site cGMP training.
  • Review and update Standard Operating Procedures, track quality investigations, process deviations and follow up to ensure corrective actions are taken.
  • Carry out duties in compliance with all state and federal regulations and guidelines, including FDA, specifically 21 CFR 111, 211 and 117.
  • Ensure compliance of Manufactured/ Packaged product to FDA and regulatory standards.
  • Monitor manufacturing / packaging process throughout its entirety.
  • Review and disposition of nonconformance product.
  • Assist Sanitation Supervisor on the overseeing of allergen program.
  • Perform ATP Swabs on equipment after allergens.

Job Requirements

QA Documentation Supervisor 

  • Minimum 3 years experience within an FDA environment
  • Ability to deal confidently and effectively with all levels of employees to express ideas concisely and in an orderly, disciplined manner – both written and orally.
  • Good understanding of cGMP and FDA regulations, specifically 21 CFR 111, 211 and 117.
  • Driven, Organized; detail oriented.
  • Able to effectively communicate in English written and oral.
  • Able to prioritize multiple work assignments.
  • Must be able to stand their ground and act in the interest of quality
  • Able to see colors.
  • Able to follow routine verbal and/or written instructions.
  • Able to work under pressure and meet deadlines.
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